Our Mission To Provide Compassionate Cancer Care to Patients with Novel Biologically Relevant Therapies
Phase I Trials:
The West Clinic is committed to providing access to early-stage clinical trials including first-in-human studies in both solid and specific hematologic malignancies. Other goals include developing biomarkers to help understand and determine optimal dose and schedule of new medications in addition to refining understanding of mechanism of action of these new therapeutics.
This phase is probably the most important step in the development of a new drug or therapy. These trials usually involve a small number of patients for whom other standard therapies have failed or no known alternative therapy is available. Phase I therapy may produce anti-cancer effects and a small number of patients may benefit. However, the primary goals of this phase are to determine anticancer activity in humans, the maximum tolerated dose of the treatment, the manner in which the drug works in the body, the toxic side effects related to different doses and whether toxic side effects are reversible. Upon completion of phase I trials, the information that has been gathered is used to begin phase II trials.
The West Clinic has participated in 46 Phase I Clinical Trials from 2005 to the present. Of these 46 studies, forty were conducted in solid tumors with the additional six in hematology.
Phase I/ New Therapeutics Program Team:
The Phase 1 clinical staff is comprised of a variety of specialized and experienced team members with extensive experience in oncology drug development and patient care. Certifications held within the Phase 1 program include Oncology Certified Nurse (OCN) and Certified Clinical Research Professional(CCRP). Together this team works to fulfill the mission to provide compassionate cancer care to patients with novel biologically relevant therapies.
Phase 1 Physcians: Daruka Mahadevan, M.D., Ph. D. is The West Clinic’s Director of the Phase I Clinical Trials Program and Associate Director of Research. Jason Chandler, MD, serves as the Associate Director of the Phase I Program. The West Clinic’s team of Medical Oncologists and Hematologists as well as Gynecologic Oncologists with Phase I experience provide additional medical coverage for patients on Phase I studies.
Research Staff: The Phase 1 research staff includes experienced OCN and CCRP certified research nurses and a Phase I CCRP certified clinical research coordinator with pharmacokinetic (PK)/pharmacodynamic (PD) experience. The research staff is closely involved with patient screening, enrollment, education, and patient follow up. They maintain constant communication with study sponsors, physicians, clinical staff, and patients.
Pharmacy Staff: Our on-site pharmacy staff includes two investigational pharmacists with experience in study drug preparation and drug accountability. Additionally, there are five experienced pharmacy technicians who are experienced at preparing study drugs according to protocol specifications.
Clinical Staff: Our treatment staff consists of experienced Phase 1 infusion nurses who are OCN certified. These RNs provide direct patient care including IV administration of study drugs with monitoring of subjects during and after infusions.
ACORN Research, LLC: ACORN is a multifaceted research organization that provides centralized site management which includes regulatory, contracts, budgeting, and data management.
Data management: The Phase 1 data management staff includes a CCRP certified Manager of Phase 1 Data Services who ensures quality and timely data entry into the paper and electronic case report forms (CRF) in addition to prompt query resolution. Additionally, on site sponsor monitoring visits are scheduled and coordinated by data management.